Tissue apposition clip application methods

ABSTRACT

Surgical methods for closing a gastrotomy. The surgical method for closing an opening in an organ wall comprises positioning a distal end portion of a steerable overtube adjacent a portion of the organ wall through which the opening extends. The surgical method further comprises inserting a flexible clip magazine into the steerable overtube. The surgical method comprises grasping tissue through which the opening extends and drawing a portion of the grasped tissue into a clamping position between upper and lower clip arms of a distal-most tissue apposition clip supported within a distal end of the clip magazine. The surgical method further comprises advancing the distal-most tissue apposition clip onto the portion of grasped tissue.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 14/515,023, entitledTISSUE APPOSITION CLIP APPLICATION METHODS, filed on Oct. 15, 2014, nowU.S. Patent Application Publication No. 2015/0032132, which is adivisional application claiming priority under 35 U.S.C. § 121 to U.S.patent application Ser. No. 12/172,766, entitled TISSUE APPOSITION CLIPAPPLICATION DEVICES AND METHODS, filed on Jul. 14, 2008, which issued onNov. 18, 2014 as U.S. Pat. No. 8,888,792, the entire disclosures ofwhich are hereby incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates, in general, to surgical devices andmethods of use and, more particularly, to devices and methods forclosing a hole or defect in a wall of tissue such as the wall of anorgan.

BACKGROUND OF THE INVENTION

Access to the abdominal cavity may, from time to time, be required fordiagnostic and therapeutic endeavors for a variety of medical andsurgical diseases. Historically, abdominal access has required a formallaparotomy to provide adequate exposure. Such “open” procedures whichrequire incisions to be made in the abdomen are not particularlywell-suited for patients that may have extensive abdominal scarring fromprevious procedures, those persons who are morbidly obese, thoseindividuals with abdominal wall infection, and those patients withdiminished abdominal wall integrity, such as patients with burns andskin grafting. Other patients simply do not want to have a scar if itcan be avoided.

Minimally invasive procedures are desirable because such procedures canreduce pain and provide relatively quick recovery times as compared withconventional open medical procedures. Many minimally invasive proceduresare performed with a flexible or rigid endoscope (including withoutlimitation laparoscopes). Such procedures permit a physician toposition, manipulate, and view medical instruments and accessoriesinside the patient through a small access opening in the patient's body.Laparoscopy is a term used to describe such an “endosurgical” approachusing an endoscope (often a rigid laparoscope). In this type ofprocedure, accessory devices are often inserted into a patient throughtrocars placed through the body wall. The trocar must pass throughseveral layers of overlapping tissue/muscle before reaching theabdominal or peritoneal cavity. One of the most significant problemsassociated with such surgical procedures is the need to provide a secureclosure of the peritoneal access site that is required for endoscopepassage and, for example, specimen removal. Prior methods required thesurgeon to close each of the muscle layers after the procedure iscompleted.

Still less invasive treatments include those that are performed throughinsertion of an endoscope through a natural body orifice to a treatmentregion such as, but not limited to within the peritoneal cavity. Many ofthese procedures employ the use of a flexible endoscope during theprocedure. Flexible endoscopes often have a flexible, steerablearticulating section near the distal end that can be controlled by theuser by utilizing controls at the proximal end. Minimally invasivetherapeutic procedures to treat diseased tissue by introducing medicalinstruments to a tissue treatment region through a natural opening ofthe patient are known as Natural Orifice Translumenal Endoscopic Surgery(NOTES)™. Examples of this approach include, but are not limited to,cystoscopy, hysteroscopy, esophagogastroduodenoscopy, and colonoscopy.However, those procedures that involve forming a hole or passage throughtissue such as, but not limited to, the stomach, the colon, the vaginalwall, esophagus, etc. still face the challenges associated with securelyclosing that hole or passage upon completion of the procedure.

Consequently a need exists for devices and methods that can be employedthrough a patient's natural orifice for closing a passage, hole, defect,incision, etc. made or otherwise ocurring through a wall of tissue suchas, for example, the stomach wall, as well as those passages or holesoccurring or extending through other tissues, organs, etc.

The foregoing discussion is intended only to illustrate some of theshortcomings present in the field of the invention at the time, andshould not be taken as a disavowal of claim scope.

SUMMARY

In one aspect of the invention, there is provided a clip applicationdevice that may include an elongate clip magazine that has an axial clippassage therein for receiving a plurality of tissue apposition clipstherein. A pair of grasper lumens may be provided in the elongate clipmagazine for accommodating grasper devices therethrough to manipulatetissue adjacent to a distal end of the elongate clip magazine. Thedevice may further include an advancement member for applying anadvancement motion to the tissue apposition clips in the axial passageto cause the tissue apposition clips to move out of the axial clippassage in seriatum.

In another general aspect of various embodiments of the presentinvention, there is provided an adapter for installing a tissueapposition clip that has upper and lower clip arms onto tissue. Invarious embodiments, the adapter may comprise a body portion that iscouplable to a distal end of an endoscope and is configured toreleasably retain a tissue apposition clip thereon such that the upperand lower clip arms are retained in an open position to enable tissue tobe drawn therebetween and thereafter be released onto the tissue uponapplication of an advancement force to the tissue apposition clip.

In still another general aspect of various embodiments of the presentinvention, there is provided a surgical method for closing an opening ina tissue wall. The method may include positioning a tissue appositionclip adjacent a distal end of an endoscope and then

positioning the tissue apposition clip adjacent the opening. The methodmay also include grasping tissue through which the opening extends anddrawing a portion of the grasped tissue into a clamping position betweenupper and lower clip arms of the tissue apposition clip. The method mayalso include advancing the tissue apposition clip onto the portion ofgrasped tissue.

Another general aspect of various embodiments of the present inventioncomprises a surgical method for closing an opening in a portion of anorgan wall. The method may include the actions of positioning a tissueapposition clip adjacent a distal end of an endoscope and positioningthe tissue apposition clip adjacent the opening. The method may furthercomprise grasping the portion of the organ wall through which theopening extends and drawing the grasped portion of the organ wall into aclamping position between upper and lower clip arms of the tissueapposition clip. In addition, the method may further comprise advancingthe tissue apposition clip onto the grasped portion of the organ walland applying at least one tissue anchor to the grasped portion or organwall clamped within the tissue apposition clip.

In another general aspect of various embodiments of the presentinvention, there is a provided a surgical method for closing an openingin a tissue wall. The method may include positioning a distal endportion of a steerable overtube adjacent a portion of the opening. Themethod may further include inserting a flexible clip magazine into thesteerable overtube, the flexible clip magazine supporting a plurality oftissue apposition clips therein such that the upper and lower clip armsthereof are supported in a spaced open position relative to each other.The flexible clip magazine may have a distal end portion received withinsaid end of the steerable overtube such that the tissue apposition clipssupported therein may be selectively discharged out through the distalend of the steerable overtube. The method may also include graspingtissue through which the opening extends and drawing a portion of thegrasped tissue into a clamping position between upper and lower cliparms of a distal-most one of the tissue apposition clips supportedwithin the distal end of the clip magazine. The method may also includeadvancing the distal-most tissue apposition clip onto the portion ofgrasped tissue.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention,and, together with the general description of the invention given above,and the detailed description of the embodiments given below, serve toexplain various principles of the present invention.

FIG. 1 is a perspective view of a tissue apposition clip embodiment ofthe present invention;

FIG. 2 is diagrammatic view of use of a clip application deviceembodiment of the present invention inserted through a natural orifice(mouth) of a patient;

FIG. 3 is a perspective view of portion of a clip application device ofthe present invention;

FIG. 4 is another perspective view of a portion of the clip applicationdevice of the present invention with graspers extending out of thedistal end thereof;

FIG. 5 is an end view of a clip magazine embodiment of the presentinvention;

FIG. 6 is a cross-sectional view of the clip application device of FIG.4 taken along line 6-6 in FIG. 4;

FIG. 7 is a side view of a grasper embodiment;

FIG. 8 is another cross-sectional view of the clip application deviceembodiment of FIG. 6 with one of the graspers thereof gripping tissue;

FIG. 9 is a partial side view of the clip application device of FIG. 8;

FIG. 10 is a partial perspective view of a portion of the clip applierapplying a clip to tissue;

FIG. 11 is a perspective view of another clip application device coupledto an endoscope;

FIG. 12 is a diagrammatic view of use of another clip application deviceembodiment of the present invention inserted through a natural orifice(mouth) of a patient;

FIG. 13 is a perspective view of an endoscope with which a clip adapterembodiment of the present invention may be used;

FIG. 14 is a perspective view of a clip adapter embodiment of thepresent invention;

FIG. 15 is an end view of the clip adapter embodiment of the FIG. 14;

FIG. 16 is a top perspective view of another a tissue apposition clipembodiment of the present invention;

FIG. 17 is a side perspective view of the tissue apposition clip of FIG.16;

FIG. 18 is a perspective view of a clip dispenser adapter embodiment onan endoscope;

FIG. 19 is an end view of the clip dispenser adapter embodiment andendoscope of FIG. 18 with a tissue apposition clip installed therein;

FIG. 20 is a side perspective view of the clip dispenser adapterembodiment of FIG. 19 with a grasper protruding out through the distalend thereof to grasp tissue;

FIG. 21 is another perspective view of the clip dispenser adapterembodiment of FIG. 20 illustrating the grasper pulling tissue in betweenthe clip arms of a clip installed therein;

FIG. 22 is a partial cross-sectional view of yet another embodiment of aclip dispenser adapter embodiment of the present invention attached tothe distal end of an endoscope;

FIG. 23 is a partial cross-sectional end view of the clip dispenseradapter embodiment of FIG. 22;

FIG. 24 is a partial cross-sectional view of yet another embodiment of aclip dispenser adapter embodiment of the present invention attached tothe distal end of an endoscope; and

FIG. 25 is a side view of a clip and clip dispenser embodiment of thepresent invention being employed with a tissue anchor applier.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the various embodiments of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician manipulating an end of theinstrument 100 that protrudes out of the natural orifice. The term“proximal” referring to the portion closest to the clinician and theterm “distal” referring to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up” and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

The present invention generally relates to devices and methods that maybe used in connection with the application of tissue apposition clipsfor closing an opening, hole, passageway, defect, etc. extending throughor occurring in a tissue wall. One example of such an opening is knownas a “gastrotomy” which comprises an opening formed to gain access tothe peritoneal cavity. However, as the present Detailed Descriptionproceeds, it will become readily apparent that the various devices andmethods disclosed herein may be successfully employed to apply clips toclose various openings, passageways, defects, etc. in a variety ofdifferent types of tissue walls, organs, etc. without departing from thespirit and scope of the present invention. “as used herein, the term“tissue wall” is intended to at least encompass all tissues and organswithin the human body or animals and includes, but is not limited to,tissue forming the abdominal wall, the stomach, the vaginal walls, theesophagus, the colon, etc. Accordingly, the various devices and methodsof the present invention and their respective equivalent structures andmethods should not be limited by the nature of the opening to be closedor the particular nature of the tissue through which the openingsextend. Furthermore, those of ordinary skill in the art will furtherappreciate that the devices and methods of the various embodiments ofthe present invention may also be successfully employed in connectionwith the application of clips in open or other laparoscopic surgicalprocedures.

FIG. 1 depicts one embodiment of a tissue apposition clip 20 of thepresent invention that may be employed to clip a portion of a tissuewall such as, for example, the stomach wall or other tissue as will bediscussed in further detail below. In various embodiments, the clips 20may be fabricated from, for example, stainless steel, Nitinol, titaniumor other deformable materials that are implantable within the body andare compatible with that type of environment. As can be seen in FIG. 1,a tissue apposition clip 20 may have a base portion 22 that separates anupper clip arm 24 and a lower clip arm 25 that extend from the base ingeneral confronting relationship to each other. The distal end portions26 of each clip arm 24, 25 are generally biased towards each other in a“clamping position” or orientation. Each distal end portion 26 may alsobe formed with two laterally extending protrusions 28, the purpose ofwhich will be discussed below. While the clip 20 depicted in FIG. 1comprises a preferred tissue apposition clip configuration, other tissueapposition clip configurations could also be employed with the clipapplication device 100 described below.

In various embodiments, a clip application device 100 of variousembodiments of the present invention may be used in connection with asteerable overtube 200. Those of ordinary skill in the art willappreciate that the clip application device 100 may be used inconnection with a variety of different steerable overtube arrangements.For example, the steerable overtube 200 may comprise a steerableovertube of the type disclosed in U.S. patent application Ser. No.11/981,134, filed Oct. 31, 2007, entitled “Endoscopic Overtubes” toGregory J. Bakos et al., the disclosure of which is herein incorporatedby reference in its entirety. Still other overtubes may be employed suchas those disclosed in U.S. Pat. No. 5,325,845 to Adair, the disclosureof which is herein incorporated by reference in its entirety. In otherembodiments, a steerable overtube of the various types disclosed incommonly owned U.S. patent application Ser. No. 12/172,782, Entitled“Endoscopic Translumenal Articulatable Steerable Overtube” to Gregory J.Bakos et al., filed on Jul. 14, 2008, now U.S. Pat. No. 8,262,563, andwhich is hereby incorporated by reference in its entirety, may besuccessfully employed. In other embodiments, a non-steerable overtubecould conceivably be employed, depending upon the application.

As can be seen in FIG. 2, one version of the steerable overtube 200 mayinterface with an actuator 220 that is used to articulate the distal endportion 222 of the overtube 200. The steerable overtube 200 has acentral lumen 202 through which various endoscopic surgical tool andinstruments may pass. See FIGS. 3 and 4. The actuator 220 may be used toselectively apply tension to cables or tension members 224 that extendthrough the wall 226 of the overtube 200 to draw the distal end portion222 thereof in a desired direction.

Although, as discussed above, the various embodiments of the presentinvention may be successfully employed to apply clips to and/or close ahole, passageway, defect, etc. in a variety of different tissue wallsand organs, one example in which the clip application 100 has particularutility is the closure of a gastrotomy created through the abdominalwall to gain access to the peritoneal cavity. FIG. 2 illustrates onemethod of deploying an embodiment of the clip application device 100 ofthe present invention through a natural orifice to close a gastrotomy.As shown in FIG. 2, the steerable overtube 200 may be inserted throughthe mouth 10 and esophagus 12 into the stomach 14, for example, toenable the surgeon to create a gastrotomy through a portion of thestomach wall. The gastrotomy may be accomplished utilizing varioussurgical instruments that are operated through the overtube. Once thegastrotomy has been created and the other surgical procedures have beencompleted, the surgical tools that have been employed up to this pointmay be removed from the overtube 200 and a clip application device 100of the present invention may be inserted through the overtube 200 andinto the stomach 14 as shown.

FIGS. 3-6 and 8-10 illustrate one embodiment of the clip applicationdevice 100 of the present invention. As can be seen in those Figures,the clip application device 100 may include an elongated clip magazine110 that is sized to extend through the central lumen 202 in thesteerable overtube 200. In various embodiments, the clip magazine 110may be extruded or otherwise formed from polyurethane, silicone, etc.such that the clip magazine 110 may flex or otherwise conform to thesteerable overtube 200. The clip magazine 110 may be formed with acentrally disposed axial clip passage 112 that is shaped to movablyaccommodate at least one and preferably a series, of clips 20 asillustrated in FIG. 6. As can be seen in FIG. 5, the axial clip passage112 may have a central passage portion 114 and four leg passage segments116 that protrude laterally from the central passage portion toaccommodate the clip arms of the clips 20. As can be seen in FIG. 6, theleg passage segments 116 may serve to support the upper clip arm 24 andthe lower clip arm 25 in a spaced open position relative to each otherto enable the clip 20 to be installed over tissue as will be discussedin further detail below.

The clip magazine 110 may further have a channel 120 formed therein foroperably supporting a conventional endoscopic video camera 130 thatcommunicates with a video display unit 132 that can be viewed by thesurgeon during the operation. See FIG. 2. In addition, an advancementchannel 140 may be provided in the clip magazine 110 for accommodatingvarious mechanisms for serially advancing the clips 20 out of the distalend of the clip magazine 110.

Also in various embodiments, the clip magazine 110 may be provided withat least one and preferably two lumens 150 for operably accommodatinggraspers 300. A variety of different known graspers may be employedwithout departing from the spirit and scope of the present invention. Ingeneral, a grasper 300 may include a pair of opposed jaws 302 a, 302 bthat are operably located at a distal end 312 of an elongate shaft 310.The proximal end of elongate shaft 310 may be coupled to a handleassembly 320 at collar 322. The handle assembly 320 may further includea fixed handle 324 that is pivotally engaged at point 326 to a movinghandle 328. Handles 324, 328 may have grasping loops 330, 332 attachedthereto for the convenient insertion of fingers or a thumb therein. Thehandle assembly 320 depicted in FIG. 7 includes a spring clip 334 andratchet 336 as two means of providing bias to handles 330, 332 such thatjaws 302 a, 302 b are urged in a closed position. Though both arepictured here together (for convenience), usually one or the other isused as means to bias jaws shut. The grasper 300 may further have anadjustable knob 340 which causes shaft 310 and therefore jaws 302 a, 302b to rotate with respect to fixed handle 330. The jaws 302 a, 302 b maybe opened and closed by manipulating the handles 324, 328. A variety ofdifferent graspers and grasper jaw configurations are known and maysuccessfully employed in connection with various embodiments of thepresent invention. Accordingly, the protections afforded to the variousembodiments of the subject invention and their equivalent structuresshould not be limited to the specific grasper configuration depicted inFIG. 7.

To use the device 100, the graspers 300 are inserted into theirrespective lumens 150 in the clip magazine 110 such that the jaws 302 a,302 b protrude out through the distal end of the clip magazine 110 asshown in FIG. 5. At least one, and preferably a plurality of, clips 20are inserted in seriatum into the axial clip passage 112 of the clipmagazine 110 and may be advanced therein in the distal direction “DD” byan advancement member 350 that may be inserted into the advancementchannel 140 in the clip magazine 110. See FIG. 6. While a variety ofdifferent clip advancement mechanisms could be used, the clipadvancement member 350 may have a distal end 352 that has a notchedportion 354 therein for engaging the proximal-most clip 20 to apply apushing force thereto in the distal direction “DD”.

When the surgeon desires to apply the clips 20 to the gastrotomy site,the distal end of the clip application device 100 is inserted in throughthe patient's mouth 10 or other natural orifice such that the graspers300 may be extended out of the distal end of the clip magazine 110 tograsp the tissue “T” as shown in FIGS. 8-10. Once the tissue “T” hasbeen acquired by the graspers 300 (as observed by the surgeon by meansof the camera 130), the surgeon may then pull the grasped tissueproximally between the spaced upper clip arm 24 and lower clip arm 25 ofthe distal-most clip 20. The surgeon may also begin to apply anadvancement force to the proximal-most clip 20 by inserting theadvancement member 350 into the advancement channel 140. The applicationof such advancement force to the proximal-most clip 20 causes the entireseries of clips 20 to move proximally in the clip magazine 110 until thedistal-most clip 20 is advanced out of the distal end of the clipmagazine 110. As can be seen in FIG. 10, the laterally extendingprotrusions 28 enable the clip 20 to ride up the elongate shaft 310 andthe jaws 302 a, 302 b of the graspers 300 to retain the upper and lowerclip arms 24, 25 in the spaced open position. The clip 20 continues tobe advanced until it engages the tissue “T” and disengages the ends ofthe grasper jaws 302 a, 302 b. At that point, the clip 20 is holding thetissue folds together and additional clips 20 may be applied in asimilar manner or the device 100 may be withdrawn from the patient.

Those of ordinary skill in the art will understand that, althoughintended to be permanent, these clips 20 may also be designed to sloughoff intentionally from the clipped tissue to enable the clips to bepassed naturally. Although not intended, it is also possible that theclips may come loose from the clipped tissue. In either case, however,it may be desirable for the clips 20 to be sized to enable the clip topass naturally from the patient without causing harm to the patient. Forexample, the clips 20 may have smooth rounded edges without significantcatch points that could hinder safe passage of the clips 20 from thebody.

FIGS. 11-15 illustrate a clip dispensing adapter 400 that may be usedwith a conventional endoscope 500. As can be seen in FIG. 12, theendoscope 500 may be passed through the steerable overtube 200 andotherwise guided thereby to the site 18 of the opening in the stomach14. One form of endoscope 500 that may be employed is illustrated inFIG. 13. As can be seen in that Figure, the endoscope 500 may have anelongate, relatively flexible body 502 that has a working channel orlumen 504 extending therethrough. In addition, the endoscope body 502may have two or more channels 506 that operably support light bundles508 therein as well as a camera channel 510 for operably accommodating avideo camera 130 therein.

On embodiment of a clip dispensing adapter 400 is depicted in furtherdetail in FIGS. 15 and 16. As can be seen in those Figures, the clipdispensing adapter 400 has a body portion 402 that is sized to fit overthe distal end 520 of the endoscope 500. In various embodiments, thebody portion 402 has an endoscope-receiving cavity 404 therein that mayhave an inner diameter that is sized relative to the outer diameter ofthe distal end 520 of the endoscope 500 such that a frictional fit isestablished therebetween when the adapter 400 is installed onto thedistal end 520. See FIG. 15. For example, in such embodiment, theadapter may be fabricated from, for example, stainless steel,polycarbonate, aluminum, etc. In other embodiments, the adapter 400 maybe affixed to the distal end 520 of the endoscope 500 by an appropriateadhesive. In still other embodiments, the adapter 400 may be fabricatedfrom a somewhat elastic material such as, for example, silicone,polyurethane, etc. to enable the adapter 400 to be slid over the distalend 520 of the endoscope 500 and retained thereon. In yet otherembodiments, the adapter 400 and the distal end 520 of the endoscope 500may be configured with threads, bayonet-type connections, ratchetconnections, etc. to enable the adapter 400 to be removed from theendoscope 500 if so desired. In other embodiments, the adapter 400 maybe permanently affixed or otherwise integrally formed into the distalend 520 of the endoscope 500.

As can be seen in FIGS. 14 and 15, the adapter 400 may further includean upper support arm 410 and a lower support arm 420 that protrudeoutward from the distal end of the body portion 402. The support arms410, 420 are spaced from each other to receive a tissue apposition clip600 therebetween. One example of a tissue apposition clip 600 that maybe employed is depicted in FIGS. 16 and 17. In various embodiments, theclip 600 may be fabricated from, for example, stainless steel, Nitinol,titanium, hard plastic, etc. and have a base portion 602 that separatesan upper clip arm 610 and a lower clip arm 620 that extend from the basein general confronting relationship to each other. The distal endportion 612 of the upper clip arm 610 and the distal end 622 of thelower clip arm 620 are generally biased towards each other in a“clamping orientation”. The distal end 612 may have a folded end portion614 and the distal end 622 may have a folded end portion 624. The endportions 614 and 624 help to facilitate installation of the clip 600 asit is advanced over folded tissue. In various embodiments, the upperclip arm 610 may have an upper opening 616 therein and an upper slot 618that extends from the upper opening 616 through the distal end portion612. Similarly, the lower clip arm 620 has a lower opening 626 and alower slot 628 extending from the lower opening 626.

FIGS. 18-21 illustrate use of the tissue apposition clip 600 with theadapter 400. For example, as can be seen in FIG. 18, the tissueapposition clip 600 may be positioned between the upper support arm 410and the lower support arm 420. Upper support arm 410 may have adownwardly extending post 414 that has retainer lug 416 formed thereonthat is sized to be received in the upper opening 616 in the upper cliparm 610. Similarly, the lower support arm 420 may have an upwardlyextending post 424 that has a retainer lug 426 thereon that is sized tobe received in the lower opening 626 in the lower clip arm 620. Thus, toinstall the tissue apposition clip 600 onto the adapter 400, the tissueapposition clip 600 is oriented between the upper support arm 410 andthe lower support arm 420 such that the upper retainer lug 414 extendsinto the opening 616 and the lower retainer lug 424 extends into theopening 626. The tissue apposition clip 600 is then moved distally suchthat the post 414 is received in the upper slot 618 and the lower post424 is received in the lower slot 628 of the clip 600 in the “open”position shown in FIG. 18.

As can be seen in FIGS. 18-21, the base portion 602 of the clip 600 mayhave a hole 604 therethrough that is aligned with a working channel 504in the endoscope 500 when the clip 600 is installed onto the adapter400. This alignment of hole 604 with the working channel 504 enables agrasper 300 to be inserted therethrough to grasp the tissue “T” as shownin FIGS. 20 and 21. Once the surgeon has grasped the target tissue “T”with the grasper 300 in the manner described above and as illustrated inFIG. 20, the surgeon can then pull the grasper 300 and tissue “T”proximally into the open tissue apposition clip 600 as shown in FIG. 21.While the surgeon is pulling the grasper 300 and tissue “T” proximally,the tissue apposition clip 600 may be pushed onto the tissue byadvancing an advancement member (rod, bar, other surgical instrument,etc.) through the working channel 505 to contact the clip base 602 andpush it distally onto the tissue “T”. When the tissue apposition clip600 is pushed distally, the lugs 416, 426 will enter the holes 616, 626,respectively in the tissue apposition clip to enable the tissueapposition clip 600 to disengage from the adapter 400 and remain on thetissue “T” as the grasper 300 is withdrawn through the hole 604 andworking channel 504.

FIGS. 22 and 23 illustrate another clip dispensing adapter 700 that maybe effectively used in connection with the tissue apposition clips 600described above. As can be seen in those Figures, the clip dispensingadapter 700 has a body portion 702 that is sized to fit over the distalend 520 of the endoscope 500. In various embodiments, the body portion702 may have an endoscope-receiving cavity 704 therein that may have aninner diameter that is sized relative to the outer diameter of thedistal end 520 of the endoscope 500 such that a frictional fit isestablished therebetween when the adapter 400 is installed onto thedistal end 520. For example, in such embodiment, the adapter may befabricated from stainless steel, aluminum, hard plastic, etc. In otherembodiments, the adapter 700 may be affixed to the distal end 520 of theendoscope 500 by an appropriate adhesive. In still other embodiments,the adapter 700 may be fabricated from a somewhat elastic material suchas, for example, silicone, polyurethane, elastomer, etc. to enable theadapter 700 to be slid over the distal end 520 of the endoscope 500 andretained thereon. In yet other embodiments, the adapter 700 and thedistal end 520 of the endoscope 500 may be configured with threads,bayonet-type connections, ratchet connections, etc. to enable theadapter 700 to be removed from the endoscope 500 if so desired. In otherembodiments, the adapter 700 may be permanently affixed or otherwiseintegrally formed into the distal end 520 of the endoscope 500.

As can be seen in FIGS. 22 and 23, the adapter 700 may further includean upper support arm 710 and a lower support arm 720 that protrudeoutward from the distal end of the body portion 702. The support arms710, 720 are spaced from each other to receive a tissue apposition clip600 therebetween. Upper support arm 410 has a downwardly extendingmovable post 714 that has retainer lug 716 formed thereon that is sizedto be received in the upper opening 616 in the upper clip arm 610. Ascan be seen in FIGS. 22 and 23, the movable post 714 is movablysupported within a slot 713 in the upper support arm 710. In variousembodiments, the movable post 714 may have laterally protruding fins 718that are received in corresponding slots 717 in the upper support arm710 such that the movable support post 714 can move in the proximaldirection “PD” and the distal direction “DD”. The movable support arm714 is biased into a retention position shown in FIG. 23 by an upperbiasing member 719. Similarly, the lower support arm 720 has an upwardlymovable post 724 that has a retainer lug 726 thereon that is sized to bereceived in the lower opening 626 in the lower clip arm 620. As can beseen in FIGS. 23 and 24, the movable post 724 is movably supportedwithin a slot 723 in the lower support arm 720. In various embodiments,the movable post 724 may have laterally protruding fins 728 that arereceived in corresponding slots 727 in the lower support arm 720 suchthat the movable support post 724 can move in the proximal direction“PD” and the distal direction “DD”. The movable support arm 724 isbiased into a retention position shown in FIG. 23 by a lower biasingmember 729.

As can also be seen in FIG. 22, an upper retraction cable 740 extendsthrough a passage 742 in the adapter 700 and is affixed to the uppermovable support post 714 and a lower retraction cable 750 extendsthrough a passage 752 in the adapter 700 and is affixed to the lowermovable support post 724. The upper and lower retraction cables 740, 750extend through corresponding passages in a flexible tube 800 thatextends over the endoscope 500. In various embodiments, the tube 800 mayinclude a helical wound coil of material that can flex with theendoscope 500 and is substantially coextensive therewith. For example,the flexible tube 800 may be fabricated from stainless steel wire. Thevarious coils 802 of the flexible tube may be provided withcorresponding holes 804 through which the retraction cables 740, 750extend. The distal end 810 of the flexible tube 800 may extend into aretention cavity 760 formed in the proximal end of the adapter body 702and be attached thereto, by pins, screws, adhesive, etc. The flexibletube 800 serves to guide the retraction cables 740, 750 along theendoscope 500 and out through the patient's mouth or other naturalorifice. Pulling on the retraction cable 740 in the proximal direction“PD, causes the upper movable post 714 to move in the proximaldirection. Likewise, pulling on the retraction cable 750 in the proximaldirection “PD” causes the lower movable post 724 to move in the proximaldirection. In alternative embodiments, each cable 740, 750 could extendthrough its own dedicated flexible coil pipe 741, 751, respectively,which would extend alongside of the endoscope. See FIG. 24.

To install the clip 600 onto the adapter 700, the clip 600 is orientedbetween the upper support arm 710 and the lower support arm 720. Oncepositioned in the adapter 700, the surgeon may then apply retractionforces to the retraction cables 740, 750 in the proximal direction suchthat the upper retainer lug 716 extends into the opening 616 and thelower retainer lug 726 extends into the opening 626 in the clip 600. Thesurgeon may then release the retraction cables 740, 750 and the upperbiasing member 719 biases the upper movable post 714 into the retentionposition and the lower biasing member 729 biases the lower movable post724 into the retention position to retain the clip 600 in positionbetween the upper and lower support arms 710, 720. The surgeon may theninsert a grasper (not shown) through the working channel in theendoscope 500 and through the clip 600 to grasp the tissue in the mannerdescribed above and then pull the tissue into a position between theupper and lower clip arms 610, 620. The surgeon may then pull theretraction cables to enable the upper and lower retainer lugs 716, 726to extend into the respective openings 616 and 626 in the clip 600 tothereby enable the clip to be pushed into the distal direction “DD” by adischarge member, bar, surgical tool inserted through the dischargelumen in the endoscope. Again the surgeon releases the grasper from thetissue and retrieves the grasper from the working channel. The clip 600remains installed on the tissue and the endoscope may then be withdrawnfrom the patient to enable another clip 600 to be installed on theadapter if addition clips are required and the process then be repeatedagain.

Another feature of clip 600 is the ability to facilitate theinstallation of tissue anchors or sutures to the clipped tissue bypassing a tissue anchor applier 900 through the endoscope 500 andthrough the hole 604 in the clip 600 as shown in FIG. 25. A variety ofsuch tissue anchor appliers are known. For example, tissue anchorapplier 900 may comprise any of the tissue anchor applying devicesdisclosed in any of the following cited documents, the disclosures ofwhich are each herein incorporated by reference in their respectiveentireties: (i) U.S. Patent Application Publication No. 2008/0103527 A1to David T. Martin et al., entitled “Flexible Endoscopic Suture AnchorApplier”, Ser. No. 11/553,489, filed Oct. 27, 2006. (ii) U.S. PatentApplication Publication No. 2007/0270907 A1, to Michael J. Stokes etal., entitled “Suture Locking Device”, Ser. No. 11/437,440, filed May19, 2006, (iii) U.S. Patent No. 2007/0270889 A1 to Sean P. Conlon etal., entitled “Combination Knotting Element and Suture AnchorApplicator”, Ser. No. 11/437,864, filed May 19, 2006, which issued onJul. 20, 2010 as U.S. Pat. No. 7,758,598, and (iv) pending co-owned U.S.patent application Ser. No. 11/796,035 to David Stefanchik et al.,entitled “Surgical Suturing Apparatus”, filed Apr. 26, 2007, whichissued on Dec. 13, 2011 as U.S. Pat. No. 8,075,572. As can be seen inFIG. 25, the needle portion 902 of the tissue anchor applier 900 isintroduced through the endoscope 500 to enable it to pierce through thetissue “T” on both sides of the opening. For example, when the openingcomprises a gastrotomy, the needle 902 of the tissue anchor applier 900may be able to pierce the tissue “T” on both sides of the gastrotomywhile remaining in the stomach. This may be a significant safetyadvantage when compared to use of prior closure systems. For example,when employing prior closure systems and methods, a mucosa-mucosaapposition is created. When employing the clip 600 of the presentinvention, a serosa-to-serosa apposition is created which may result ina more secure/permanent healing of the gastrotomy.

As can be readily appreciated from the foregoing, the variousembodiments of the present invention described above represent a vastimprovement over prior devices and methods used to apply tissueapposition clips for closing gastrotomies. The unique and novel featuresof the various embodiments of the present invention enable the operationto be performed through a natural orifice in the patient and therebyavoid several disadvantages associated with other conventional surgicalmethods and procedures that require incisions to be made into theabdomen. The present invention may comprise a device that containsseveral clips that may be serial advanced onto tissue that is graspedand manipulated using conventional tissue grasping devices. Otherembodiments may comprise a clip dispensing adapter that may be appliedto a distal end of a conventional endoscope and, if desired, suppliedand/or sold separately from the endoscope. Such adapters may be pressedonto, threaded onto or otherwise temporarily attached to the distal endof the endoscope to complete the above-described procedure andthereafter removed from the endoscope and discarded or reprocessed forfuture use. Other embodiments of the present invention contemplatepermanent attachment of the adapter to the distal end of the endoscopeand still other embodiments envision that the adapter may be integrallyformed on the distal end of the endoscope.

While several embodiments of the invention have been described, itshould be apparent, however, that various modifications, alterations andadaptations to those embodiments may occur to persons skilled in the artwith the attainment of some or all of the advantages of the invention.For example, according to various embodiments, a single component may bereplaced by multiple components, and multiple components may be replacedby a single component, to perform a given function or functions. Thisapplication is therefore intended to cover all such modifications,alterations and adaptations without departing from the scope and spiritof the disclosed invention as defined by the appended claims.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include an combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of particular pieces or parts of thedevice can be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Those ofordinary skill in the art will appreciate that the reconditioning of adevice can utilize a variety of different techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

Preferably, the inventions described herein will be processed beforesurgery. First a new or used endoscope is obtained and, if necessary,cleaned. The endoscope can then be sterilized. In one sterilizationtechnique, the endoscope is placed in a closed and sealed container,such as a plastic or TYVEK® bag. The container and endoscope are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or higher energy electrons. The radiation killsbacteria on the endoscope and in the container. The sterilized endoscopecan then be stored in the sterile container. The sealed container keepsthe endoscope sterile until it is opened in the medical facility.

Any patent, publication, application or other disclosure material, inwhole or in part, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

The invention which is intended to be protected is not to be construedas limited to the particular embodiments disclosed. The embodiments aretherefore to be regarded as illustrative rather than restrictive.Variations and changes may be made by others without departing from thespirit of the present invention. Accordingly, it is expressly intendedthat all such equivalents, variations and changes which fall within thespirit and scope of the present invention as defined in the claims beembraced thereby.

What is claimed is:
 1. A surgical method for closing an opening in anorgan wall, said surgical method comprising: positioning a distal endportion of a steerable overtube adjacent a portion of the organ wallthrough which the opening extends; inserting a flexible clip magazineinto the steerable overtube, the flexible clip magazine supporting aplurality of tissue apposition clips therein such that upper and lowerclip arms thereof are supported in a spaced open position relative toeach other, said flexible clip magazine having a distal end portionreceived within said distal end portion of the steerable overtube suchthat the tissue apposition clips supported therein may be selectivelydischarged out through the distal end portion of the steerable overtube;grasping tissue through which the opening extends; drawing a portion ofthe grasped tissue into a clamping position between upper and lower cliparms of a distal-most one of the tissue apposition clips supportedwithin the distal end portion of the clip magazine; and advancing thedistal-most tissue apposition clip onto the portion of grasped tissue.2. The surgical method of claim 1 further comprising: repositioning thedistal end portion of the steerable overtube adjacent another portion ofthe opening; grasping other tissue through which the opening extends;drawing a portion of the grasped other tissue into a clamping positionbetween upper and lower clip arms of another distal-most one of thetissue apposition clips supported within the distal end portion of theclip magazine; and advancing the another distal-most tissue appositionclip onto the portion of grasped other tissue.
 3. The surgical method ofclaim 1 wherein the opening in the organ wall is selected from a groupof openings consisting of an opening in a stomach, an opening in acolon, an opening in a vagina, and an opening in an esophagus.
 4. Thesurgical method of claim 1 further comprising clamping the distal-mostone of the tissue apposition clips onto the portion of grasped tissuewhen the portion of the grasped tissue is drawn into the clampingposition between the upper and lower clip arms.
 5. The surgical methodof claim 4, wherein clamping the distal-most one of the tissueapposition clips onto the portion of the grasped tissue creates aserosa-to-serosa apposition.
 6. The surgical method of claim 4, whereingrasping tissue through which the opening extends comprises passing alumen through holes in the tissue apposition clips.
 7. A surgical methodfor closing an opening in a portion of an organ wall, said surgicalmethod comprising: positioning a tissue apposition clip adjacent adistal end of an endoscope; positioning the tissue apposition clipadjacent the opening; grasping the portion of the organ wall throughwhich the opening extends; drawing the grasped portion of the organ wallinto a clamping position between upper and lower clip arms of the tissueapposition clip; advancing the tissue apposition clip onto the graspedportion of the organ wall; and applying at least one tissue anchor tothe grasped portion of organ wall within the tissue apposition clip. 8.The surgical method of claim 7 wherein said positioning the tissueapposition clip adjacent the distal end of the endoscope, comprises:coupling a clip dispensing adapter to the distal end of the endoscope;releasably supporting the tissue apposition clip on the clip dispensingadapter; and movably manipulating the distal end of the endoscope andadapter adjacent to the opening through the portion of organ wall. 9.The surgical method of claim 8 wherein said positioning the tissueapposition clip adjacent the distal end of the endoscope comprisesinserting the distal end of the endoscope and adapter through a naturalorifice in a patient and manipulating the distal end of the endoscopeand adapter by applying actuation forces thereto from a portion of theendoscope positioned external to the natural orifice.
 10. The surgicalmethod of claim 7 wherein said applying at least one tissue anchor tothe grasped portion of organ wall within the tissue apposition clipcomprises inserting a tissue anchor applier through a hole in the tissueapposition clip to operably engage the grasped portion of organ wallwithin the tissue apposition clip.
 11. The surgical method of claim 7further comprising clamping the tissue apposition clip onto graspedportion of organ when the grasped portion of organ is drawn into theclamping position between the upper and lower clip arms.
 12. Thesurgical method of claim 11, wherein clamping the tissue apposition cliponto the portion of the grasped tissue creates a serosa-to-serosaapposition.
 13. A surgical method for closing an opening in tissue, saidsurgical method comprising: positioning a tissue apposition clipadjacent a distal end of an endoscope; positioning the tissue appositionclip adjacent the opening in the tissue; grasping a portion of thetissue through which the opening extends; drawing the portion of thegrasped tissue into a position between upper and lower clip arms of thetissue apposition clip; and advancing the tissue apposition clip ontothe portion of grasped tissue.
 14. The surgical method of claim 13further comprising clamping the tissue apposition clip onto the portionof grasped tissue.
 15. The surgical method of claim 14, wherein clampingthe tissue apposition clip onto the portion of the grasped tissuecreates a serosa-to-serosa apposition.
 16. The surgical method of claim13 wherein said positioning the tissue apposition clip adjacent thedistal end of the endoscope, comprises: coupling a clip dispensingadapter to the distal end of the endoscope; releasably supporting thetissue apposition clip on the clip dispensing adapter; and movablymanipulating the distal end of the endoscope and adapter adjacent to theopening.
 17. The surgical method of claim 13 further comprising applyingat least one tissue anchor to the portion of grasped tissue within thetissue apposition clip.
 18. The surgical method of claim 17 wherein saidapplying at least one tissue anchor to the portion of grasped tissuewithin the tissue apposition clip comprises inserting a tissue anchorapplier through a hole in the tissue apposition clip to operably engagethe portion of grasped tissue within the tissue apposition clip.
 19. Thesurgical method of claim 13, wherein grasping the tissue through whichthe opening extends comprising passing a lumen through holes in thetissue apposition clips to grasp a portion of the tissue.
 20. Thesurgical method of claim 13 wherein the opening in the tissue comprisesan opening in an organ wall.